ACHIEVING WORLD STANDARDS THROUGH QUALITY IN PROCESS - CII Nimish Shroff93.pdf · ¾orjlfdo iorz ri...
Transcript of ACHIEVING WORLD STANDARDS THROUGH QUALITY IN PROCESS - CII Nimish Shroff93.pdf · ¾orjlfdo iorz ri...
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ACHIEVING WORLD ACHIEVING WORLD STANDARDS THROUGH STANDARDS THROUGH QUALITY IN PROCESSQUALITY IN PROCESS
Presented by,Nimish Shroff (Director)M/s. Charak Pharma Pvt. Ltd.
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CONTENTSINTRODUCTION
REQUIREMENTS AS PER GMP
• QUALITY MANAGEMENT SYSTEMS• PPERSONNEL• PPREMISES AND EQUIPMENT• DDOCUMENTATION• MMANUFACTURING• QQUALITY CONTROL & ASSURANCE• IINSPECTION
PREMISES AND EQUIPMENT REQUIREMENTS
• CHANGE ROOMS – PRIMARY / SECONDARY• WWAREHOUSE AREA• MMANUFACTURING AREA• QQUALITY ASSURANCE & CONTROL AREA
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REQUIREMENTS AS PER GMP
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PREMISES AND EQUIPMENT REQUIREMENTS
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DESIGN
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DEDICATED AREAS
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SAMPLE OF FACTORY LAYOUT
personnelpackaging materialsraw/bulk materials
FIN
ISH
ED
PR
OD
UC
TS
S
TOR
AG
E A
RE
A
AP
PR
OV
ED
PM
AIR LOCK
WEIGHING
LABELING/PACKAGING
LABELING/PACKAGING
LABELING/PACKAGING
FILLING
FILLING
COMPOUNDING COMPOUNDING
LABELING/PACKAGING
COMPOUNDING/ FILLING
CLEAN EQUIPMENTSTORAGE
WASHINGAREA
QUALITY CONTROL AREA
FEMALE
MALE
FILLING
LOCKERS
LOCKERS
MICRO
BULK STORAGE
BU
LK
ST
OR
AG
E
BU
LK
ST
OR
AG
E
LAB
EL
STO
RA
GE
/C
OD
ING
AR
EA
QU
AR
AN
TIN
E
AR
EA
RE
JEC
T
AR
EA
SA
MP
LING
RM
APPROVEDRM
RE
CE
IVIN
G
Material flow through plastic door
Finished products
LAYOUT
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CHANGE ROOM IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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CHANGE ROOM AS PER GMP
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CHANGE ENTRY / EXIT FOR PRIMARY
CHANGE ROOM AS PER GMP
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ENTRY / EXIT FOR
SECONDARY CHANGE ROOM AS PER GMP
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WAREHOUSE AS PER GMP NORMS
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WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
RECEIVING OF RAW MATERIAL
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LOADING & UNLOADING AS PER GMP
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HERB’S STORE
WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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SUGAR STORE
WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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UNDER TEST AREA REJECTED AREA
WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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RECEIVING BAY RM & PM
RECEIPT OF
RAW & PACKING MATERIAL AS PER GMP
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MATERIAL ENTRY
SAMPLING AREA
MAN ENTRY
SAMPLING AREA AS PER GMP
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CLEANED SAMPLING DEVICES
SAMPLING OF RAW MATERIALS AS PER GMP
SAMPLING BOOTH
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STORGE OF RAW MATERIALS AS PER GMP
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A.C. STORAGE AREA AS PER GMP
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QUARANTINE & REJECTED AREAS AS PER GMP
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WEIGHING & DISPENSING
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DISPENSING OF RAW MATERIALS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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WEIGHING & DISPENSING AS PER GMP
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STORAGE OF PRIMARY PACKING MATERIALS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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STORAGE OF PRINTED PACKING MATERIAL AS PER GMP
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A.C. STORAGE OF PRIMARY PACKING MATERIAL AS PER GMP
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MANUFACTURING & PACKING AREAS
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FLOORS
CONSTRUCTION AS PER GMP
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WALLS & CEILINGS AS PER GMP
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FLOOR
CEILING WITHOUT JOINT
CEILING WITH JOINT
WALLS & CEILINGS AS PER GMP
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THE JOINTS OF ALL SURFACES
THE DESIGNS OF WINDOWS AND THE WAY THEY FIT INTO THE FRAMES
JOINTS & FRAMES AS PER GMP
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X
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VENTILATION AS PER GMP
’
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MANUFACTURING AREA AS PER GMP
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DISTILLATION ASSEMBLY
EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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LIQUID MANUFACTURING TANKS
EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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MANUFACTURING TANK
EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
TANK WITH STIRRER
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EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP
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LIQUID MANUFACTURING VESSELS
EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP
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MULTIMILL
HYDRAULIC LIFTER
SIFTER
DOUBLE E CONBLENDER
EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP
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CAPSULE FILLING MACHINE
EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP
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RAPID MIXER GRANULATOR
EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP
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FLUIDISED BED DRYER
FBD BOWL TRANSFER TO CONTA BIN
EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP
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BLENDER WITH CONTA BIN
EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP
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EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP
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NEOCOTA – TABLET COATING SYSTEM
EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP
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PACKAGING AREA IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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PACKAGING AREA IN A CONVENTIONAL HERBAL MANUFACTURING UNIT
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PACKAGING AREA AS PER GMP
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BOTTLE WASHING MACHINE
EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP
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BOTTLE FILLING & SEALING MACHINE
EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP
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VISUAL INSPECTION
EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP
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BLISTER PACKING MACHINE
EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP
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VISUAL INSPECTION AT CONVEYER BELT
EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP
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QUALITY ASSURANCE &
CONTROL AREAREFERENCE STANDARD
RECORD CUPBOARDREAGENT & SOLVENT
LABORATORY APPARATUS
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CONCLUSION
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Thank You !